This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.
This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration. Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Administered by intravenous (IV) infusion over 3-4 hours
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, Japan
ALBI score
Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin \[mg/dL\] x 17.1) x 0.66 + (albumin \[g/dL\] x 10 x -0.085)
Time frame: Baseline to 24 weeks after administration
Child-Pugh score
Change from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration. Child-Pugh score is determined by scoring the following five clinical measures. Encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, slight = 2 points, moderate = 3 points Bilirubin: \< 2 mg/dL = 1 point, 2 to 3 mg/dL = 2 points, \> 3 mg/dL = 3 points Albumin: \> 3.5 g/dL = 1 point, 2.8 to 3.5 g/dL = 2 points, \< 2.8 g/dL = 3 points Prothrombin Time (%): \> 70% = 1 point, 40 to 70% = 2 points, \< 40% = 3 points
Time frame: Baseline to 12, 24 and 28 weeks after administration
ALBI score
Change from baseline in ALBI score at 12 and 28 weeks after administration.
Time frame: Baseline to 12 and 28 weeks after administration
Liver stiffness measurement by FibroScan
Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration.
Time frame: Baseline to 12 and 24 weeks after administration
Serum fibrosis markers
Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration.
Time frame: Baseline to 12 and 24 weeks after administration
Serum albumin
Change from baseline in serum albumin at 12, 24 and 28 weeks after administration.
Time frame: Baseline to 12, 24 and 28 weeks after administration
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Serum bilirubin
Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration.
Time frame: Baseline to 12, 24 and 28 weeks after administration
PT%
Change from baseline in PT% at 12, 24 and 28 weeks after administration.
Time frame: Baseline to 12, 24 and 28 weeks after administration
MELD score
Change from baseline in MELD score at 12, 24 and 28 weeks after administration. The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. The higher the score, the more serious the subject's disease. MELD is calculated according to the following formula: MELD score = 3.78 x ln(serum bilirubin \[mg/dL\]) + 11.2 x ln(PT-INR) + 9.57 x ln(serum creatinine \[mg/dL\]) + 6.43
Time frame: Baseline to 12, 24 and 28 weeks after administration
FIB-4 index
Change from baseline in FIB-4 index at 12, 24 and 28 weeks after administration. FIB-4 index = (Age \[years\] x AST \[U/L\]) / (Platelet Count \[10\*9/L\] x √ ALT \[U/L\] )
Time frame: Baseline to 12, 24 and 28 weeks after administration
mALBI grade
Percentage of subjects who achieved \>= 1 stage improvement in mALBI grade from baseline at 12, 24 and 28 weeks after administration. Based on ALBI score, mALBI grade is classified into Grade 1 to 3 shown below. mALBI grade: Grade 1: \<=-2.60; Grade 2a: \>-2.60 to \<-2.27; Grade 2b: \>=-2.27 to -1.39; Grade 3: \>-1.39
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification
Percentage of subjects who changed from grade B at baseline to grade A at 12, 24 and 28 weeks after administration in Child-Pugh classification. Based on the total points in Child-Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points), the severity of the disease is classified into Grade A to C shown below. Child-Pugh classification: Grade A: 5 to 6 points -\> Compensated cirrhosis; Grade B: 7 to 9 points -\> Decompensated cirrhosis; Grade C: 10 to 15 points -\> Decompensated cirrhosis
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh score
Percentage of subjects who achieved \>= 2 points improvement from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.
Time frame: Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification and score
Percentage of subjects who changed from grade B to grade A in Child-Pugh classification and achieved \>= 2 points improvement in Child-Pugh score from baseline at 12, 24 and 28 weeks after administration.
Time frame: Baseline to 12, 24 and 28 weeks after administration